This is a small phase I study with dose escalation and dose expansion cohorts. The former cohort will need up to 12 subjects with advanced solid tumor to define feasibility and recommended phase 2 dose (RP2D); the latter up to 10 subjects to further define safety. Study subjects will be adults with advanced solid tumor (dose escalation) and advanced non-small cell lung cancer (NSCLC) who progressed on at least one first-line systemic therapy (dose expansion).
Name: Epacadostat
Description: Epacadostat tablet: 100mg or 300mgType: DrugSirolimus/Epacadostat Dose Escalation Sirolimus/Epacadostat Dose Expansion
Name: sirolimus
Description: Sirolimus tablet: 1mg, 2mg, 3mg, or 6mgType: DrugSirolimus/Epacadostat Dose Escalation Sirolimus/Epacadostat Dose Expansion
Description: Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 will be used to measure incidence of treatment-emergent adverse events.
Measure: Incidence of treatment-emergent adverse events. Time: 28 daysDescription: Subjects will be assessed every 8 weeks by radiologic imaging to monitor disease status.
Measure: Overall response response in subjects with NSCLC (dose expansion cohort) Time: up to 12 monthsDescription: Subjects will be assessed at Week 8 by radiologic imaging to monitor disease status.
Measure: Disease control rate (DCR) >40% in subjects with NSCLC (dose expansion cohort) Time: 2 monthsDescription: Subjects will be assessed every 8 weeks by radiologic imaging to monitor disease status.
Measure: Median progression free survival (mPFS) >3 months in subjects with NSCLC (dose expansion cohort) Time: up to 12 monthsDescription: Subjects will be assessed every 8 weeks by radiologic imaging to monitor disease status.
Measure: Median Overall Survival (mOS) > 6 months in subjects with NSCLC (dose expansion cohort) Time: up to 12 monthsAllocation: Non-Randomized
Sequential Assignment
There is one SNP
- Dose escalation: subjects with advanced and unresectable solid tumor who progressed on at least one line of systemic therapy, and no approved therapy or standard therapy with demonstrated clinical benefit exists; and all subjects with T790M mutation positive NSCLC have progressed on osimertinib. --- T790M ---